Urinary Tract InfectionsPhase 3REASSURENCT05584657
Oral Sulopenem Versus Amoxicillin/Clavulanate for Uncomplicated Urinary Tract Infection in Adult Women
A Phase 3 study testing Sulopenem etzadroxil/probenecid and Amoxicillin/clavulanate in people with Urinary Tract Infections and Cystitis, run by Iterum Therapeutics, International Limited at 167 sites in United States.
Trial summary
Study 310 is a clinical study which compares the effectiveness of oral sulopenem versus oral amoxicillin/clavulanate for the treatment of adult women with uncomplicated urinary tract infection. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Tract Infections, Cystitis
- What is being tested?
- Sulopenem etzadroxil/probenecid and Amoxicillin/clavulanate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,229 participants
- Where
- 167 sitesUnited States
- Study dates
- 18 Oct 2022to 21 Nov 2023
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients ≥18 years of age with ≥24 hours and ≤96 hours of urinary symptoms attributable to a UTI
- Two of the following signs and symptoms of uUTI: urinary frequency, urinary urgency, pain or burning on micturition, suprapubic pain.
- A mid-stream urine specimen with evidence of pyuria as defined by either a machine-read dipstick positive for leukocyte esterase OR at least 10 white blood cells per cubic millimeter on microscopic analysis of unspun urine OR white blood cell count ≥10 cells/high-powered field (HPF) in the sediment of a spun urine
Who cannot join
- Presence of signs and symptoms suggestive of acute pyelonephritis defined as: fever (temperature > 38° Celsius), chills, costovertebral angle tenderness, flank pain, nausea, and/or vomiting
- Receipt of antibacterial drug therapy potentially effective as treatment of uUTI within the prior 7 days
- Concurrent use of non-study treatments that would have a potential effect on outcome evaluations in patients with uUTI, including analgesics (e.g., non-steroidal anti-inflammatory drugs, aspirin, paracetamol etc.), phenazopyridine, and cranberry products.
- Any anatomical abnormality of the urinary tract, including surgically modified urinary tract anatomy, and obstructive uropathy due to nephrolithiasis, stricture, tumor, or fibrosis
- Ongoing urinary retention
- Neurogenic bladder
Show all 12Show fewer
- Current resident of a long-term care facility
- Instrumentation of urinary tract in the previous 30 days
- An indwelling urinary catheter, ureteral stent or other foreign material in the urinary tract
- Any history of trauma to the pelvis or urinary tract
- Receiving hemodialysis, hemofiltration, peritoneal dialysis, or had a renal transplant
- History of allergy or hypersensitivity to carbapenems, β-lactams or probenecid, as formulated with their excipients
Trial locations and contacts
167 sites in 1 country.
167 sites in 1 country
United States167 sites
Medical Facility2
Albuquerque, New Mexico, 87102
Medical Facility
Albuquerque, New Mexico, 87109
Medical Facility3
Atlanta, Georgia, 30309
Medical Facility2
Atlanta, Georgia, 30329
Medical Facility
Atlanta, Georgia, 30342
Medical Facility
Austin, Texas, 78723
Medical Facility
Aventura, Florida, 33180
Medical Facility
Bakersfield, California, 93309
Medical Facility
Beaver, Pennsylvania, 15009
Medical Facility
Blackfoot, Idaho, 83221
Medical Facility
Boynton Beach, Florida, 33435
Medical Facility
Brooklyn, New York, 11215
Medical Facility2
Brooklyn, New York, 11229
Medical Facility
Cape Coral, Florida, 33909
Medical Facility
Carrollton, Texas, 75007
Medical Facility2
Carrollton, Texas, 75010
Medical Facility
Charleston, South Carolina, 29414
Medical Facility
Charlotte, North Carolina, 28277
Medical Facility2
Chattanooga, Tennessee, 37404
Medical Facility
Chattanooga, Tennessee, 37421
Medical Facility
Chicago, Illinois, 60643
Medical Facility
Chula Vista, California, 91911
Medical Facility
Cincinnati, Ohio, 45219
Medical Facility
Columbia, Maryland, 21045
Medical Facility2
Columbus, Ohio, 43213
Medical Facility
Columbus, Ohio, 43228
Medical Facility
Corpus Christi, Texas, 78404
Medical Facility
Cullman, Alabama, 35055
Medical Facility
Dallas, Texas, 75209
Medical Facility
Dayton, Ohio, 45409
Medical Facility2
Dayton, Ohio, 45424
Medical Facility
Decatur, Georgia, 30034
Medical Facility
Doral, Florida, 33166
Medical Facility 2
Draper, Utah, 84020
Medical Facility
Draper, Utah, 84020
Medical Facility
Easley, South Carolina, 29640
Medical Facility
Edgewater, Florida, 32132
Medical Facility
Eugene, Oregon, 97404
Medical Facility
Eunice, Louisiana, 70535
Medical Facility
Falls Church, Virginia, 22042
Medical Facility
Fayette, Mississippi, 39069
Medical Facility
Frisco, Texas, 75033
Medical Facility
Fullerton, California, 92835
Medical Facility
Garden City, New York, 11530
Medical Facility
Garden Grove, California, 92844
Medical Facility
Georgetown, Texas, 79628
Medical Facility
Grand Junction, Colorado, 81501
Medical Facility
Great Falls, Montana, 59405
Medical Facility
Greensboro, North Carolina, 27405
Medical Facility
Greenville, South Carolina, 29607
Medical Facility
Gulfport, Mississippi, 39503
Medical Facility
Hendersonville, Tennessee, 37075
Medical Facility
Hialeah, Florida, 33016
Medical Facility
Hollywood, Florida, 33024
Medical Facility
Homestead, Florida, 33032
Medical Facility2
Hot Springs, Arkansas, 71901
Medical Facility
Hot Springs, Arkansas, 71913
Medical Facility2
Houston, Texas, 77036
Medical Facility
Houston, Texas, 77074
Medical Facility
Huntington Beach, California, 92648
Medical Facility 2
Huntington Park, California, 90255
Medical Facility
Huntington Park, California, 90255
Medical Facility2
Idaho Falls, Idaho, 08340
Medical Facility
Idaho Falls, Idaho, 83404
Medical Facility
Irvine, California, 92614
Medical Facility
Jackson, Mississippi, 39202
Medical Facility
Kalispell, Montana, 59901
Medical Facility
Kingwood, Texas, 77339
Medical Facility
Kingwood, West Virginia, 26537
Medical Facility
La Mesa, California, 91942
Medical Facility
Lake Worth, Florida, 33460
Medical Facility2
Lake Worth, Florida, 33461
Medical Facility
Lakewood, Colorado, 80228
Medical Facility
Lancaster, California, 93534
Medical Facility
Lancaster, South Carolina, 29720
Medical Facility2
Las Vegas, Nevada, 89113
Medical Facility
Las Vegas, Nevada, 89121
Medical Facility
Lawrenceville, Georgia, 30046
Medical Facility
League City, Texas, 77573
Medical Facility
Leesburg, Florida, 34748
Medical Facility
Lima, Ohio, 45805
Medical Facility
Lomita, California, 90717
Medical Facility2
Los Angeles, California, 90017
Medical Facility
Los Angeles, California, 90057
Medical Facility
Manassas, Virginia, 20110
Medical Facility
Mandeville, Louisiana, 70471
Medical Facility
Marrero, Louisiana, 70072
Medical Facility2
McKinney, Texas, 75069
Medical Facility
McKinney, Texas, 75070
Medical Facility
Memphis, Tennessee, 38120
Medical Facility2
Mesquite, Texas, 75149
Medical Facility
Mesquite, Texas, 75149
Medical Facility
Metairie, Louisiana, 70001
Medical Facility3
Miami, Florida, 33126
Medical Facility2
Miami, Florida, 33135
Medical Facility
Miami, Florida, 33165
Medical Facility9
Miami, Florida, 33173
Medical Facility5
Miami, Florida, 33175
Medical Facility8
Miami, Florida, 33176
Medical Facility6
Miami, Florida, 33179
Medical Facility7
Miami, Florida, 33184
Medical Facility4
Miami, Florida, 33186
Medical Facility
Miami Beach, Florida, 33140
Medical Facility
Miami Gardens, Florida, 33056
Medical Facility2
Miami Lakes, Florida, 33016
Medical Facility
Miami Lakes, Florida, 33317
Medical Facility
Middleburg Heights, Ohio, 44130
Medical Facility
Missoula, Montana, 59804
Medical Facility
Missouri City, Texas, 77459
Medical Facility
Morgantown, West Virginia, 26505
Medical Facility
Myrtle Beach, South Carolina, 29572
Medical Facility
Nashville, Tennessee, 37209
Medical Facility
New Bern, North Carolina, 28562
Medical Facility
New Orleans, Louisiana, 70124
Medical Facility2
New Orleans, Louisiana, 70127
Medical Facility
Norfolk, Virginia, 23502
Medical Facility
Orlando, Florida, 32806
Medical Facility2
Orlando, Florida, 32812
Medical Facility
Ormond Beach, Florida, 32174
Medical Facility
Oxon Hill, Maryland, 20745
Medical Facility
Pearland, Texas, 77584
Medical Facility
Peoria, Arizona, 85381
Medical Facility3
Phoenix, Arizona, 85031
Medical Facility
Phoenix, Arizona, 85032
Medical Facility2
Phoenix, Arizona, 85051
Medical Facility2
Plano, Texas, 75024
Medical Facility
Plano, Texas, 75093
Medical Facility
Pleasant Grove, Utah, 84062
Medical Facility
Pomona, California, 91768
Medical Facility
Pompano Beach, Florida, 33060
Medical Facility
Portland, Oregon, 97202
Medical Facility
Powdersville, South Carolina, 29611
Medical Facility
Prairieville, Louisiana, 70769
Medical Facility
Ridgeland, Mississippi, 39157
Medical Facility
Sacramento, California, 95821
Medical Facility
Salt Lake City, Utah, 84107
Medical Facility
San Antonio, Texas, 78215
Medical Facility
San Diego, California, 92111
Medical Facility
Saraland, Alabama, 36571
Medical Facility
Schenectady, New York, 12304
Medical Facility
Scottdale, Pennsylvania, 15683
Medical Facility
Seneca, South Carolina, 29678
Medical Facility
Sheffield, Alabama, 35660
Medical Facility
Shreveport, Louisiana, 71106
Medical Facility
Smithfield, Pennsylvania, 15478
Medical Facility 2
Sugar Land, Texas, 77479
Medical Facility3
Sugar Land, Texas, 77479
Medical Facility
Sugar Land, Texas, 77479
Medical Facility
Summerville, South Carolina, 29485
Medical Facility
Sweetwater, Florida, 33172
Medical Facility
Tamarac, Florida, 33321
Medical Facility
Tampa, Florida, 33603
Medical Facility3
Tampa, Florida, 33607
Medical Facility4
Tampa, Florida, 33607
Medical Facility2
Tampa, Florida, 33614
Medical Facility5
Tampa, Florida, 33634
Medical Facility
The Bronx, New York, 10456
Medical Facility
Towson, Maryland, 21204
Medical Facility
Tucson, Arizona, 85715
Medical Facility
Tulsa, Oklahoma, 74133
Medical Facility
Union City, Georgia, 30291
Medical Facility
Upland, California, 91786
Medical Facility
Upper Saint Clair, Pennsylvania, 15241
Medical Facility
Victorville, California, 92395
Medical Facility
Winston-Salem, North Carolina, 27103
Medical Facility
Winter Haven, Florida, 33880
Medical Facility
Woodstock, Georgia, 30189
About this study
Official title: A Prospective, Phase 3, Randomized, Multi-center, Double-blind Study of the Efficacy, Tolerability, and Safety of Oral Sulopenem Etzadroxil/Probenecid Versus Oral Amoxicillin/Clavulanate for Treatment of Uncomplicated Urinary Tract Infections (uUTI) in Adult Women
Study 310 is a clinical study which compares the effectiveness of oral sulopenem versus oral amoxicillin/clavulanate for the treatment of adult women with uncomplicated urinary tract infection.
Read the detailed description
IT001-310 is a Phase 3, randomized, multicenter, double-blind, double dummy, controlled study to compare oral sulopenem etzadroxil/probenecid (oral sulopenem) to oral amoxicillin/clavulanate for the treatment of adult female patients with uncomplicated urinary tract infection. Approximately 1966 adult women with uncomplicated urinary tract infection will be randomized in a 1:1 fashion to receive either oral sulopenem etzadroxil/probenecid or oral amoxicillin/clavulanate twice daily for 5 days. The primary outcome measure for efficacy evaluation will be the overall success (combined clinical and microbiologic success) on Day 12 (± 1 day)/Test of Cure (TOC).
- Conditions
- Urinary Tract Infections, Cystitis
- Being tested
- Sulopenem etzadroxil/probenecid, Amoxicillin/clavulanate
- Medical subject headings
- Urinary Tract Infections, Cystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sulopenem etzadroxil/probenecidDrug
Also called Oral sulopenem
Oral sulopenem twice daily for 5 days
Amoxicillin/clavulanateDrug
Also called Augmentin
Oral Augmentin twice daily for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Sulopenem etzadroxil/probenecid | Experimental | Sulopenem etzadroxil/probenecid 500 mg/500 mg PO twice daily for 5 days Receives: Drug: Sulopenem etzadroxil/probenecid |
| Amoxicillin/clavulanate | Active comparator | Amoxicillin/clavulanate PO twice daily for 5 days Receives: Drug: Amoxicillin/clavulanate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Success
Clinical Success (resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms) AND Microbiologic success (eradication of the baseline pathogen)
Measured: Day 12+/-1 day
Overall Success Susceptible Population
Clinical Success (resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms) AND Microbiologic success (eradication of the baseline pathogen)
Measured: Day 12+/-1 day
Secondary outcomes (5)
Clinical Success Modified Intent-to-treat Population
Resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms
Measured: Day 12+/-1 day
Clinical Success
Resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms
Measured: Day 12+/-1 day
Clinical Success Susceptible Population
Resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms
Measured: Day 12+/-1 day
Microbiologic Success
Eradication of the Baseline Pathogen
Measured: Day 12+/-1 day
Microbiologic Success Susceptible Population
Microbiologic Success: Eradication of the Baseline Pathogen
Measured: Day 12+/-1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start18 Oct 2022
- Primary completion3 Nov 2023
- Study completion21 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,229 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iterum Therapeutics, International Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sailaja Puttagunta, MD, Study director, Iterum Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05584657
- Sponsor's protocol ID
- IT001-310
- Acronym
- REASSURE
- Status last verified
- Oct 2024
- First submitted
- 14 Oct 2022
- Last updated
- 20 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
- Expanded access
- Available
Publications
Puttagunta S, Aronin SI, Gupta J, Das AF, Gupta K, Dunne MW. Sulopenem versus Amoxicillin/Clavulanate for the Treatment of Uncomplicated Urinary Tract Infection. NEJM Evid. 2025 Jul;4(7):EVIDoa2400414. doi: 10.1056/EVIDoa2400414. Epub 2025 Jun 24.
PubMed 40552968